SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)

NCT07021794 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-05

No results posted yet for this study

Summary

This placebo-controlled, randomized, blinded, two-arm phase II study will test the safety and potential efficacy of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.

Conditions

  • Post-COVID / Long-COVID

Interventions

DRUG

Placebo

A single dose of placebo (saline) indistinguishable from the active drug in appearance

BIOLOGICAL

Sipavibart

A single intramuscular dose of Sipavibart, 300 mg

Sponsors & Collaborators

  • Florida Department of Health

    collaborator OTHER_GOV
  • Nancy Klimas

    lead OTHER

Principal Investigators

  • Nancy Klimas, MD · Nova Southeastern University

  • Amanpreet Cheema, PhD · Nova Southeastern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021794 on ClinicalTrials.gov